Cognitive Impairment, MildNCT04593290
Listen Carefully: An Exploratory Study of the Association Between Listening Effort and Cognitive Function
A study testing Oticon Opn S 1 miniRITE hearing aid in people with Cognitive Impairment, Mild and Hearing Loss, run by Technical University of Denmark at 1 site in Denmark.
Trial summary
This study aims to investigate the association between listening effort and cognitive function for both cognitively healthy individuals and for patients with Mild Cognitive Impairment (MCI) in mid-to-late stages of life, and furthermore to investigate listening effort and cognitive function after several weeks of… Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Mild, Hearing Loss
- What is being tested?
- Oticon Opn S 1 miniRITE hearing aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Aug 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is 40-85 years old;
- Has no other significant neurological or psychiatric disease;
- Has normal hearing (0 - 25 dB thresholds from 250 -6 kHz) measured using PTA;
- Has normal or corrected to normal vision;
- Has an MCI diagnosis, according to Winblad criteria, with a score on the Mini Mental State Examination (MMSE) less than or equal to 26 (MMSE ≤ 26);
- Has a CDR = 0.5;
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- Speaks Danish as native language
- (For part 2 of the study - hearing aid use) has a live-in informant.
- Is 40-85 years old;
- Has a score above 26 on the Mini Mental State Examination (MMSE) (MMSE > 26);
- Has a CDR Global score = 0;
- Has no significant neurological or psychiatric disease;
- Has Normal hearing (0 - 25 dB thresholds from 250 -6 kHz) measured using PTA;
- Has Normal or corrected to normal vision;
- Speaks Danish as a native language.
Who cannot join
- Takes medication or treatment that could impact the pupillary dilation: eye drops (e.g. atropine or phenylephrine);
- Takes medication or treatment that could impact cognitive function;
- Abuses alcohol or drugs;
- Is unable to comply with study procedures.
- Cognitively healthy group:
- Meets the criteria for MCI (Winblad criteria) or dementia (ICD 10);
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- Takes medication or treatment that could impact the pupillary dilation: eye drops (e.g. atropine or phenylephrine);
- Takes medication or treatment that could impact cognitive function;
- Abuses alcohol or drugs;
- Is unable to comply with study procedures.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen Memory Clinic, Rigshospitalet
Copenhagen, Region H, 2100
About this study
This study aims to investigate the association between listening effort and cognitive function for both cognitively healthy individuals and for patients with Mild Cognitive Impairment (MCI) in mid-to-late stages of life, and furthermore to investigate listening effort and cognitive function after several weeks of hearing aid use. Listening effort is measured by the recording of peak pupil dilation during a sentence-final word identification and recall (SWIR) test, cognitive performance is measured using a battery of pen and paper cognitive tests, and hearing loss is measured with pure tone audiometry (PTA). A select number of participants in both the cognitively healthy and MCI group will be administered hearing aids, and the study will re-test both listening effort and cognitive performance.
Read the detailed description
This is an exploratory proof-of-concept study and an exploratory intervention study with hearing aids in the context of listening effort. With a case (MCI) and control group (cognitively healthy), investigators will examine the associations between listening effort and cognitive function and assess the effect of hearing aid use on both listening effort and cognitive function test scores for those without hearing impairment. There is not sufficient literature to support a sample size calculation for this association study. Investigators will recruit approximately 50 participants. Half of these participants (n=25) will be individuals who have been diagnosed with MCI, according to the Winblad criteria (ICD10), with a Mini Mental State Examination (MMSE) score ≤ 26. The control group of participants (n=25) will be cognitively healthy individuals. All participants will undergo both listening effort testing, coupled with pupillometry and cognitive performance testing, based on a battery of pen-and-paper neuropsychological tests.
As investigators aim to measure cognitive effort exerted when listening and understanding speech in noise, is important that all study participants exhibit a normal sensitivity threshold within the ear canal. This will be assessed using Pure Tone Audiometry (PTA).
Assessment scores for cognitive function will be recorded in a clinical setting, and will be based on a battery of pen-and-paper neuropsychological cognitive tests. The Stroop Test, Trail Making Test (part A \& B), Symbol Digit Modalities Test (SDMT), Verbal Fluency Tests (category: animals and lexical), Rey Complex Figure Test and Logical Memory Test (Part A) will be administered.
The objective measure of listening effort, pupil dilation, will be recorded as a measure of task performance accuracy and pupil dilation will be measured during a SWIR test, which is used to measure speech identification and recall in varying background noise. Prior to the SWIR test, participants undergo an adaptive Danish Hearing in Noise Test (HINT), comprising a list of equally intelligible sentences to be repeated in varying decibel (dB) levels of background noise to determine the individual's speech reception threshold (SRT) at 80% correct responses.
During the SWIR test, the participant is fitted with PupilLabs' eye-tracking system, an open source system consisting of clip-in eye tracking hardware to be placed in a Virtual Reality (VR) headset. To prevent floor and ceiling effects that are independent to baseline pupil size, the illumination within the VR display is individually adapted to the individual's midpoint prior to data collection between dim (~30 lux) and bright (~230 lux), with an average illuminance of 110 lux. A software suite allows the capture and post-processing of the data feed, including pupil diameter. For the purpose of this study, the PupilLabs software is controlled via a MATLAB interface.
Everyone who participates in Part 1 (listening effort testing and cognitive testing) will be invited to participate in Part 2 (hearing aids). It is not a requirement to participate in the administration, 6-week use, and re-testing procedures involved in Part 2 of the study. All cognitively healthy participants will be invited to participate, only MCI patients with a live-in informant will be given this opportunity. After ear measurement and dome and wire length selection, Oticon Opn S 1 miniRITE hearing aid fitting will occur wirelessly using Genie software, followed by hearing aid use instructions. The fitting will use Open domes, the second generation of the National Acoustic Laboratories (NAL) fitting protocol (NAL-NL2) and will increase gain seven steps on top of Real Ear Unaided Gain (REUG) from 750 Hz to 6 kHz.
- Conditions
- Cognitive Impairment, Mild, Hearing Loss
- Being tested
- Oticon Opn S 1 miniRITE hearing aid
- Medical subject headings
- Cognitive Dysfunction, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oticon Opn S 1 miniRITE hearing aidDevice
Everyone who participates in Part 1 (listening effort testing and cognitive testing) will be invited to participate in Part 2 (hearing aids). It is not a requirement to participate in the administration, 6-week use, and re-testing procedures involved in Part 2 of the study. All cognitively healthy participants will be invited to participate, only MCI patients with a live-in informant will be given this opportunity. After ear measurement and dome and wire length selection, Oticon Opn S 1 miniRITE hearing aid fitting will occur wirelessly using Genie software, followed by hearing aid use instructions. The fitting will use Open domes, the standard NAL-NL2 protocol, and will increase gain seven steps on top of Real Ear Unaided Gain (REUG) from 750 Hz to 6 kHz.
| Study group | Role | What they receive |
|---|---|---|
| Mild Cognitive Impairment (MCI) | Experimental | MCI is defined as an early stage of cognitive decline that lies between normal age-matched cognitive function and the onset of very mild forms of dementia, and is associated with a slight but noticeable decline in abilities such as memory and thinking skills. Listening effort testing (with pupillometry) and cognitive testing will be administered for this group - and after a 6-week period of hearing aid use, these measures will be re-tested. Receives: Device: Oticon Opn S 1 miniRITE hearing aid |
| Cognitively Healthy | Active comparator | This group is 40-85 years old and has no significant neurological or psychiatric disease. Listening effort testing (with pupillometry) and cognitive testing will be administered for this group - and after a 6-week period of hearing aid use, these measures will be re-tested. Receives: Device: Oticon Opn S 1 miniRITE hearing aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Listening effort
Listening effort will be measured by the percent of correctly recalled words in the SWIR test and the time-bound pattern in the pupil dilation traces during the SWIR test.
Measured: Baseline, pre-intervention
The Stroop Color and Word test
Neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect.
Measure: time (seconds) and number of mistakes.
Increased time corresponds to poorer performance. Increased mistakes correspond to poorer performance.
Measured: Baseline, pre-intervention
Rey Complex Figure Test
Neuropsychological assessment, administered by trained neuropsychologist, where examinees are asked to reproduce a complicated line drawing, first by copying it freehand and then drawing it from recall. This tests both recognition and recall, and uses visuospatial abilities, memory, attention, planning, working memory and executive functions.
Measure: Accuracy scores between 0 and 2 on 18 figure elements (from 0 to a maximum of 36) on both copy and delayed recall
Higher score = improved performance
Measured: Baseline, pre-intervention
Symbol-Digit Modalities Test
Neuropsychological assessment commonly used in clinical and research settings to assess neurological dysfunction. The participant has 90 seconds to pair specific numbers with given geometric figures. Like other substitution tasks, performance is underpinned by attention, perceptual speed, motor speed, and visual scanning.
Measure: Total score based on number of pairings made in 90 seconds ( maximum of 110 pairings).
Higher score corresponds to improved performance.
Measured: Baseline, pre-intervention
Trail Making Test A and B
Neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. Test A has participants follow numbers sequentially, while Test B has participants follow alternating numbers and letters, sequentially. The test can provide information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning.
Measure: Test A - total time (seconds) required to connect 25 numbers, Test B - total time (seconds) required to connect 13 numbers and alphabet to letter H.
Increased time corresponds to poorer performance.
Measured: Baseline, pre-intervention
Verbal Fluency Test (category and lexical)
Participants are given 1 minute to produce as many unique words as possible within a semantic category (category fluency) or starting with a given letter (letter fluency). Category fluency tasks rely on language representations of semantic concepts, whereas lexical and action word task rely more on the central executive component of working memory.
Measure: Number of unique words identified within 1 minute.
More words correspond to improved performance.
Measured: Baseline, pre-intervention
Logical Memory Test A
The Logical Memory test (part A) is a subtest of the Wechsler Memory Scale-Revised, and is a standardised assessment of narrative episodic memory. A short story is orally presented and the examinee is asked to recall the story verbatim. 25-35 minutes later, free recall of the story is again elicited (delayed recall), and a series of 30 questions are asked about the story.
Measure: scores between 0 and 1 on specific pieces of the story (maximum score of 25) in both immediate and delayed recall. For the questions, a score of 0 or 1 is given to the corresponding 30 questions (maximum score of 30).
Higher score corresponds to improved performance.
Measured: Baseline, pre-intervention
Secondary outcomes (7)
Listening effort post-hearing aid use
Listening effort will be measured by the percent of correctly recalled words in the SWIR test and the time-bound pattern in the pupil dilation traces during the SWIR test.
Measured: Post-intervention, after 6 weeks of intervention (hearing aid use)
Logical Memory Test A post-hearing aid use
The Logical Memory test (part A) is a subtest of the Wechsler Memory Scale-Revised, and is a standardised assessment of narrative episodic memory. A short story is orally presented and the examinee is asked to recall the story verbatim. 25-35 minutes later, free recall of the story is again elicited (delayed recall), and a series of 30 questions are asked about the story.
Measure: scores between 0 and 1 on specific pieces of the story (maximum score of 25) in both immediate and delayed recall. For the questions, a score of 0 or 1 is given to the corresponding 30 questions (maximum score of 30).
A higher score corresponds to improved performance
Measured: Post-intervention, after 6 weeks of intervention (hearing aid use)
Verbal Fluency Test (category and lexical) post-hearing aid use
Participants are given 1 minute to produce as many unique words as possible within a semantic category (category fluency) or starting with a given letter (letter fluency). Category fluency tasks rely on language representations of semantic concepts, whereas lexical and action word task rely more on the central executive component of working memory.
Measure: Number of unique words identified within 1 minute.
More words corresponds to improved performance.
Measured: Post-intervention, after 6 weeks of intervention (hearing aid use)
Trail Making Test A and B - post-hearing aid use
Neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. Test A has participants follow numbers sequentially, while Test B has participants follow alternating numbers and letters, sequentially. The test can provide information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning.
Measure: Test A - total time (seconds) required to connect 25 numbers, Test B - total time (seconds) required to connect 13 numbers and alphabet to letter H.
Increased time corresponds to poorer performance.
Measured: Post-intervention, after 6 weeks of intervention (hearing aid use)
Symbol-Digit Modalities Test
Neuropsychological assessment commonly used in clinical and research settings to assess neurological dysfunction. The participant has 90 seconds to pair specific numbers with given geometric figures. Like other substitution tasks, performance is underpinned by attention, perceptual speed, motor speed and visual scanning.
Measure: Total score based on number of pairings made in 90 seconds ( maximum of 110 pairings).
Higher score corresponds to improved performance.
Measured: Post-intervention, after 6 weeks of intervention (hearing aid use)
Rey Complex Figure Test
Neuropsychological assessment where participants are asked to reproduce a complicated line drawing, first by copying it freehand and then drawing it from recall. This tests both recognition and recall, and uses visuospatial abilities, memory, attention, planning, working memory and executive functions.
Measure: Accuracy scores between 0 and 2 on 18 figure elements (from 0 to a maximum of 36) on both copy and delayed recall.
Higher score corresponds to improved performance.
Measured: Post-intervention, after 6 weeks of intervention (hearing aid use)
The Stroop Color and Word test
Neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect.
Measure: time (seconds) and number of mistakes.
Increased time corresponds to poorer performance. Increased mistakes correspond to poorer performance.
Measured: Post-intervention, after 6 weeks of intervention (hearing aid use)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start8 Aug 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cognitive Impairment, MildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Dementia Research Centre
- Responsible party
- Principal investigator, Anja Maier, Technical University of Denmark
- Investigators
- Anja Maier, Ph.D., Principal investigator, DTU - Technical University of Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593290
- Sponsor's protocol ID
- 19042404
- Status last verified
- Apr 2022
- First submitted
- 5 Jun 2020
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pichora-Fuller MK, Kramer SE, Eckert MA, Edwards B, Hornsby BW, Humes LE, Lemke U, Lunner T, Matthen M, Mackersie CL, Naylor G, Phillips NA, Richter M, Rudner M, Sommers MS, Tremblay KL, Wingfield A. Hearing Impairment and Cognitive Energy: The Framework for Understanding Effortful Listening (FUEL). Ear Hear. 2016 Jul-Aug;37 Suppl 1:5S-27S. doi: 10.1097/AUD.0000000000000312.
PubMed 27355771Zekveld AA, Kramer SE, Festen JM. Cognitive load during speech perception in noise: the influence of age, hearing loss, and cognition on the pupil response. Ear Hear. 2011 Jul-Aug;32(4):498-510. doi: 10.1097/AUD.0b013e31820512bb.
PubMed 21233711Dawes P, Emsley R, Cruickshanks KJ, Moore DR, Fortnum H, Edmondson-Jones M, McCormack A, Munro KJ. Hearing loss and cognition: the role of hearing AIDS, social isolation and depression. PLoS One. 2015 Mar 11;10(3):e0119616. doi: 10.1371/journal.pone.0119616. eCollection 2015.
PubMed 25760329Panza F, Solfrizzi V, Logroscino G. Age-related hearing impairment-a risk factor and frailty marker for dementia and AD. Nat Rev Neurol. 2015 Mar;11(3):166-75. doi: 10.1038/nrneurol.2015.12. Epub 2015 Feb 17.
PubMed 25686757Livingston G, Huntley J, Sommerlad A, Ames D, Ballard C, Banerjee S, Brayne C, Burns A, Cohen-Mansfield J, Cooper C, Costafreda SG, Dias A, Fox N, Gitlin LN, Howard R, Kales HC, Kivimaki M, Larson EB, Ogunniyi A, Orgeta V, Ritchie K, Rockwood K, Sampson EL, Samus Q, Schneider LS, Selbaek G, Teri L, Mukadam N. Dementia prevention, intervention, and care: 2020 report of the Lancet Commission. Lancet. 2020 Aug 8;396(10248):413-446. doi: 10.1016/S0140-6736(20)30367-6. Epub 2020 Jul 30. No abstract available.
PubMed 32738937Griffiths TD, Lad M, Kumar S, Holmes E, McMurray B, Maguire EA, Billig AJ, Sedley W. How Can Hearing Loss Cause Dementia? Neuron. 2020 Nov 11;108(3):401-412. doi: 10.1016/j.neuron.2020.08.003. Epub 2020 Aug 31.
PubMed 32871106Feldman A, Patou F, Baumann M, Stockmarr A, Waldemar G, Maier AM, Vogel A. Listen Carefully protocol: an exploratory case-control study of the association between listening effort and cognitive function. BMJ Open. 2022 Mar 9;12(3):e051109. doi: 10.1136/bmjopen-2021-051109.
PubMed 35264340
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Listen Carefully: An Exploratory Study of the Association Between Listening Effort and Cognitive Function
- ClinicalTrials.gov ID
- NCT04593290
- Acronym / sponsor ID
- 19042404
- Conditions
- Cognitive Impairment, Mild, Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Technical University of DenmarkUniversity, hospital or other
- Collaborators
- Danish Dementia Research Centre
- Study start
- 8 Aug 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the association between listening effort and cognitive function for both cognitively healthy individuals and for patients with Mild Cognitive Impairment (MCI) in mid-to-late stages of life, and furthermore to investigate listening effort and cognitive function after several weeks of hearing aid use. Listening effort is measured by the recording of peak pupil dilation during a sentence-final word identification and recall (SWIR) test, cognitive performance is measured using a battery of pen and paper cognitive tests, and hearing loss is measured with pure tone audiometry (PTA). A select number of participants in both the cognitively healthy and MCI group will be administered hearing aids, and the study will re-test both listening effort and cognitive performance.
Detailed description
This is an exploratory proof-of-concept study and an exploratory intervention study with hearing aids in the context of listening effort. With a case (MCI) and control group (cognitively healthy), investigators will examine the associations between listening effort and cognitive function and assess the effect of hearing aid use on both listening effort and cognitive function test scores for those without hearing impairment. There is not sufficient literature to support a sample size calculation for this association study. Investigators will recruit approximately 50 participants. Half of these participants (n=25) will be individuals who have been diagnosed with MCI, according to the Winblad criteria (ICD10), with a Mini Mental State Examination (MMSE) score ≤ 26. The control group of participants (n=25) will be cognitively healthy individuals. All participants will undergo both listening effort testing, coupled with pupillometry and cognitive performance testing, based on a battery of pen-and-paper neuropsychological tests.
As investigators aim to measure cognitive effort exerted when listening and understanding speech in noise, is important that all study participants exhibit a normal sensitivity threshold within the ear canal. This will be assessed using Pure Tone Audiometry (PTA).
Assessment scores for cognitive function will be recorded in a clinical setting, and will be based on a battery of pen-and-paper neuropsychological cognitive tests. The Stroop Test, Trail Making Test (part A \& B), Symbol Digit Modalities Test (SDMT), Verbal Fluency Tests (category: animals and lexical), Rey Complex Figure Test and Logical Memory Test (Part A) will be administered.
The objective measure of listening effort, pupil dilation, will be recorded as a measure of task performance accuracy and pupil dilation will be measured during a SWIR test, which is used to measure speech identification and recall in varying background noise. Prior to the SWIR test, participants undergo an adaptive Danish Hearing in Noise Test (HINT), comprising a list of equally intelligible sentences to be repeated in varying decibel (dB) levels of background noise to determine the individual's speech reception threshold (SRT) at 80% correct responses.
During the SWIR test, the participant is fitted with PupilLabs' eye-tracking system, an open source system consisting of clip-in eye tracking hardware to be placed in a Virtual Reality (VR) headset. To prevent floor and ceiling effects that are independent to baseline pupil size, the illumination within the VR display is individually adapted to the individual's midpoint prior to data collection between dim (~30 lux) and bright (~230 lux), with an average illuminance of 110 lux. A software suite allows the capture and post-processing of the data feed, including pupil diameter. For the purpose of this study, the PupilLabs software is controlled via a MATLAB interface.
Everyone who participates in Part 1 (listening effort testing and cognitive testing) will be invited to participate in Part 2 (hearing aids). It is not a requirement to participate in the administration, 6-week use, and re-testing procedures involved in Part 2 of the study. All cognitively healthy participants will be invited to participate, only MCI patients with a live-in informant will be given this opportunity. After ear measurement and dome and wire length selection, Oticon Opn S 1 miniRITE hearing aid fitting will occur wirelessly using Genie software, followed by hearing aid use instructions. The fitting will use Open domes, the second generation of the National Acoustic Laboratories (NAL) fitting protocol (NAL-NL2) and will increase gain seven steps on top of Real Ear Unaided Gain (REUG) from 750 Hz to 6 kHz.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mild Cognitive Impairment (MCI) | Experimental | Device: Oticon Opn S 1 miniRITE hearing aidMCI is defined as an early stage of cognitive decline that lies between normal age-matched cognitive function and the onset of very mild forms of dementia, and is associated with a slight but noticeable decline in abilities such as memory and thinking skills. Listening effort testing (with pupillometry) and cognitive testing will be administered for this group - and after a 6-week period of hearing aid use, these measures will be re-tested. |
| Cognitively Healthy | Active comparator | Device: Oticon Opn S 1 miniRITE hearing aidThis group is 40-85 years old and has no significant neurological or psychiatric disease. Listening effort testing (with pupillometry) and cognitive testing will be administered for this group - and after a 6-week period of hearing aid use, these measures will be re-tested. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Is 40-85 years old;
- Has no other significant neurological or psychiatric disease;
- Has normal hearing (0 - 25 dB thresholds from 250 -6 kHz) measured using PTA;
- Has normal or corrected to normal vision;
- Has an MCI diagnosis, according to Winblad criteria, with a score on the Mini Mental State Examination (MMSE) less than or equal to 26 (MMSE ≤ 26);
Key exclusion criteria (10 listed)
- Takes medication or treatment that could impact the pupillary dilation: eye drops (e.g. atropine or phenylephrine);
- Takes medication or treatment that could impact cognitive function;
- Abuses alcohol or drugs;
- Is unable to comply with study procedures.
- Meets the criteria for MCI (Winblad criteria) or dementia (ICD 10);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oticon Opn S 1 miniRITE hearing aidEveryone who participates in Part 1 (listening effort testing and cognitive testing) will be invited to participate in Part 2 (hearing aids). It is not a requirement to participate in the administration, 6-week use, and re-testing procedures involved in Part 2 of the study. All cognitively healthy participants will be invited to participate, only MCI patients with a live-in informant will be given this opportunity. After ear measurement and dome and wire length selection, Oticon Opn S 1 miniRITE hearing aid fitting will occur wirelessly using Genie software, followed by hearing aid use instructions. The fitting will use Open domes, the standard NAL-NL2 protocol, and will increase gain seven steps on top of Real Ear Unaided Gain (REUG) from 750 Hz to 6 kHz. | Device | Cognitively Healthy, Mild Cognitive Impairment (MCI) |
Primary outcome
Listening effort
Time frame: Baseline, pre-intervention
Listening effort will be measured by the percent of correctly recalled words in the SWIR test and the time-bound pattern in the pupil dilation traces during the SWIR test.
The Stroop Color and Word test
Time frame: Baseline, pre-intervention
Neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect. Measure: time (seconds) and number of mistakes. Increased time corresponds to poorer performance. Increased mistakes correspond to poorer performance.
Rey Complex Figure Test
Time frame: Baseline, pre-intervention
Neuropsychological assessment, administered by trained neuropsychologist, where examinees are asked to reproduce a complicated line drawing, first by copying it freehand and then drawing it from recall. This tests both recognition and recall, and uses visuospatial abilities, memory, attention, planning, working memory and executive functions. Measure: Accuracy scores between 0 and 2 on 18 figure elements (from 0 to a maximum of 36) on both copy and delayed recall Higher score = improved performance
Symbol-Digit Modalities Test
Time frame: Baseline, pre-intervention
Neuropsychological assessment commonly used in clinical and research settings to assess neurological dysfunction. The participant has 90 seconds to pair specific numbers with given geometric figures. Like other substitution tasks, performance is underpinned by attention, perceptual speed, motor speed, and visual scanning. Measure: Total score based on number of pairings made in 90 seconds ( maximum of 110 pairings). Higher score corresponds to improved performance.
Trail Making Test A and B
Time frame: Baseline, pre-intervention
Neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. Test A has participants follow numbers sequentially, while Test B has participants follow alternating numbers and letters, sequentially. The test can provide information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning. Measure: Test A - total time (seconds) required to connect 25 numbers, Test B - total time (seconds) required to connect 13 numbers and alphabet to letter H. Increased time corresponds to poorer performance.
Verbal Fluency Test (category and lexical)
Time frame: Baseline, pre-intervention
Participants are given 1 minute to produce as many unique words as possible within a semantic category (category fluency) or starting with a given letter (letter fluency). Category fluency tasks rely on language representations of semantic concepts, whereas lexical and action word task rely more on the central executive component of working memory. Measure: Number of unique words identified within 1 minute. More words correspond to improved performance.
Logical Memory Test A
Time frame: Baseline, pre-intervention
The Logical Memory test (part A) is a subtest of the Wechsler Memory Scale-Revised, and is a standardised assessment of narrative episodic memory. A short story is orally presented and the examinee is asked to recall the story verbatim. 25-35 minutes later, free recall of the story is again elicited (delayed recall), and a series of 30 questions are asked about the story. Measure: scores between 0 and 1 on specific pieces of the story (maximum score of 25) in both immediate and delayed recall. For the questions, a score of 0 or 1 is given to the corresponding 30 questions (maximum score of 30). Higher score corresponds to improved performance.
7 secondary outcomes
Listening effort post-hearing aid use
Time frame: Post-intervention, after 6 weeks of intervention (hearing aid use)
Logical Memory Test A post-hearing aid use
Time frame: Post-intervention, after 6 weeks of intervention (hearing aid use)
Verbal Fluency Test (category and lexical) post-hearing aid use
Time frame: Post-intervention, after 6 weeks of intervention (hearing aid use)
Trail Making Test A and B - post-hearing aid use
Time frame: Post-intervention, after 6 weeks of intervention (hearing aid use)
Symbol-Digit Modalities Test
Time frame: Post-intervention, after 6 weeks of intervention (hearing aid use)
Rey Complex Figure Test
Time frame: Post-intervention, after 6 weeks of intervention (hearing aid use)
The Stroop Color and Word test
Time frame: Post-intervention, after 6 weeks of intervention (hearing aid use)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Background: PubMed 27355771Pichora-Fuller MK, Kramer SE, Eckert MA, Edwards B, Hornsby BW, Humes LE, Lemke U, Lunner T, Matthen M, Mackersie CL, Naylor G, Phillips NA, Richter M, Rudner M, Sommers MS, Tremblay KL, Wingfield A. Hearing Impairment and Cognitive Energy: The Framework for Understanding Effortful Listening (FUEL). Ear Hear. 2016 Jul-Aug;37 Suppl 1:5S-27S. doi: 10.1097/AUD.0000000000000312.
- Background: PubMed 21233711Zekveld AA, Kramer SE, Festen JM. Cognitive load during speech perception in noise: the influence of age, hearing loss, and cognition on the pupil response. Ear Hear. 2011 Jul-Aug;32(4):498-510. doi: 10.1097/AUD.0b013e31820512bb.
- Background: PubMed 25760329Dawes P, Emsley R, Cruickshanks KJ, Moore DR, Fortnum H, Edmondson-Jones M, McCormack A, Munro KJ. Hearing loss and cognition: the role of hearing AIDS, social isolation and depression. PLoS One. 2015 Mar 11;10(3):e0119616. doi: 10.1371/journal.pone.0119616. eCollection 2015.
- Background: PubMed 25686757Panza F, Solfrizzi V, Logroscino G. Age-related hearing impairment-a risk factor and frailty marker for dementia and AD. Nat Rev Neurol. 2015 Mar;11(3):166-75. doi: 10.1038/nrneurol.2015.12. Epub 2015 Feb 17.
- Background: PubMed 32738937Livingston G, Huntley J, Sommerlad A, Ames D, Ballard C, Banerjee S, Brayne C, Burns A, Cohen-Mansfield J, Cooper C, Costafreda SG, Dias A, Fox N, Gitlin LN, Howard R, Kales HC, Kivimaki M, Larson EB, Ogunniyi A, Orgeta V, Ritchie K, Rockwood K, Sampson EL, Samus Q, Schneider LS, Selbaek G, Teri L, Mukadam N. Dementia prevention, intervention, and care: 2020 report of the Lancet Commission. Lancet. 2020 Aug 8;396(10248):413-446. doi: 10.1016/S0140-6736(20)30367-6. Epub 2020 Jul 30. No abstract available.
- Background: PubMed 32871106Griffiths TD, Lad M, Kumar S, Holmes E, McMurray B, Maguire EA, Billig AJ, Sedley W. How Can Hearing Loss Cause Dementia? Neuron. 2020 Nov 11;108(3):401-412. doi: 10.1016/j.neuron.2020.08.003. Epub 2020 Aug 31.
- Derived from this study: PubMed 35264340Feldman A, Patou F, Baumann M, Stockmarr A, Waldemar G, Maier AM, Vogel A. Listen Carefully protocol: an exploratory case-control study of the association between listening effort and cognitive function. BMJ Open. 2022 Mar 9;12(3):e051109. doi: 10.1136/bmjopen-2021-051109.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anja Maier, Ph.D. principal investigator
DTU - Technical University of Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oticon Opn S 1 miniRITE hearing aid in people with Cognitive Impairment, Mild and Hearing Loss, run by Technical University of Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Listening effort (time frame: Baseline, pre-intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04593290, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.